WO2023124594A1

WO2023124594A1 - Vascular stenosis treatment apparatus

Info

Publication number: WO2023124594A1
Application number: PCT/CN2022/131923
Authority: WO
Inventors: 李晓强; 冯海全; 王晓天; 王永刚; 董书恒; 施俭; 鲍路姿
Original assignee: 苏州天鸿盛捷医疗器械有限公司
Priority date: 2021-12-31
Filing date: 2022-11-15
Publication date: 2023-07-06
Also published as: CN116407210A

Abstract

Provided is a vascular stenosis treatment apparatus, comprising a treatment assembly (1), the treatment assembly (1) comprising: a balloon (11), the wall of the balloon (11) being provided with a plurality of first holes (114) for liquid to pass through, and the balloon (11) having an unexpanded state and an expanded state; a covering member (12), the covering member (12) covering the outside of the balloon (11) and expanding with the expansion of the balloon (11), the covering member (12) having a plurality of second holes (124), and when the balloon (11) is in the expanded state, the aperture of the first hole (114) being smaller than the aperture of the second hole (124). The vascular stenosis treatment apparatus can achieve accurate positioning, and the coating member (12) has a limiting effect on a drug solution, so that the drug can more uniformly and effectively act on a desired position of a vascular wall, thus further increasing the utilization rate of the drug, reducing the occurrence rate of vascular restenosis, and improving the treatment effect.

Description

A device for treating vascular stenosis

technical field

The invention belongs to the field of medical equipment, and in particular relates to a treatment device for vascular stenosis.

Background technique

Since the 1970s, percutaneous transluminal balloon angioplasty has been used to treat vascular stenosis caused by atherosclerosis and revascularization of occluded vessels. Inserted into the vascular system, under external pressure, the balloon inflates at the narrowed part of the blood vessel, so as to apply radial pressure to the inner wall of the blood vessel, widen the narrowed and occluded area, and make blood flow better. Although the immediate effect of balloon angioplasty is satisfactory, the balloon catheter dilation may damage the vessel due to balloon over-inflation, or in the treatment of severe hard calcified lesions due to the insufficient performance of the balloon itself, so that the effective treatment of the vessel cannot be achieved. Expansion, which leads to high incidence of surgical complications of balloon angioplasty, especially restenosis, therefore, limits its wide application in clinic.

In order to improve the therapeutic effect of the balloon, drug-coated balloons have appeared in the prior art, but the binding force of the drug on the surface of the balloon is weak, so in the process of delivering the balloon to the lesion, a large amount of drugs have been lost and The amount of drug loss is uncontrollable, resulting in large fluctuations in the drug concentration received by the vessel wall.

Another method for treating vascular stenosis in the prior art is intravascular stenting, which is to implant a stent at the stenotic part of the blood vessel. This method can effectively reduce the rate of restenosis in the blood vessel, but there are still 20-30% of patients. In-stent restenosis is difficult to manage.

In order to improve the therapeutic effect of endovascular stenting, drug-coated stents have appeared in the prior art. Due to the presence of drug-loaded polymer coatings on the stent, long-term irritation occurs between the stent and the inner wall of the blood vessel, which easily causes late thrombus. In addition, for stenotic lesions with severe calcification, because the stent cannot fully adhere to the wall, the drug cannot play its role, which eventually leads to in-stent restenosis.

Drug thrombolysis is mostly used in clinical emergency because of the risk of massive bleeding, and thrombolytic drugs should not be injected continuously for a long time (generally no more than 3 to 5 days), otherwise it is easy to cause adverse reactions such as massive bleeding. Mechanical thrombectomy uses proximal vacuum suction or distal contact with the thrombus to pull it into the proximal catheter to remove the thrombus and restore blood perfusion. However, because the old thrombus is difficult to break, it often cannot enter the suction catheter smoothly or is captured by mechanical thrombectomy devices such as the catheter thrombus retrieval grid, which may lead to prolongation of the thrombus removal operation time and adverse consequences such as excessive blood loss in patients.

Contents of the invention

The object of the present invention is to provide a device for treating blood vessel stenosis with different structures.

In order to solve the problems of the technologies described above, the present invention adopts the following technical solutions:

A device for the treatment of vascular stenosis, comprising a treatment assembly, the treatment assembly comprising:

a balloon having a plurality of first holes in its wall for passage of fluid, the balloon having an unexpanded state and an expanded state;

A covering member, the covering member covers the outside of the balloon and expands with the expansion of the balloon, the covering member has a plurality of second holes, when the balloon is in the expanded state , the diameter of the first hole is smaller than the diameter of the second hole.

Specifically, when the balloon is transformed from an unexpanded state to an expanded state, both the first hole on the balloon and the second hole on the covering member become larger, and the balloon is in the In the expanded state, the enlargement degree of the second hole is larger than that of the first hole.

Specifically, the covering rate of the outer peripheral surface of the balloon by the covering member in the unexpanded state is greater than the covering rate of the outer peripheral surface of the balloon by the covering member in the expanded state.

The coverage rate in the unexpanded state refers to the sum of the projected areas of the covering on the cylindrical shape when the covering and the balloon are both in the unexpanded state, and the outer peripheral surface of the roughly cylindrical balloon is 100%. The percentage of the outer peripheral surface of the balloon is the coverage.

The coverage in the expanded state refers to the coverage as the percentage of the sum of the projected areas of the covering on the outer peripheral surface of the balloon to the outer peripheral surface of the balloon when both the covering and the balloon are in the expanded state.

According to some specific and preferred embodiments, in the expanded state, the positions of the plurality of first holes correspond to the positions of the plurality of second holes, so that between the balloon and the covering member A plurality of relatively independent administration spaces are formed between them.

According to some specific and preferred embodiments, in the unexpanded state, the position of the first hole corresponds to the position of the second hole.

According to some specific and preferred embodiments, one second hole is correspondingly provided with one or more first holes.

Further, when one of the second holes is correspondingly provided with one of the first holes, the axis line of the first hole coincides with the axis line of the second hole; when one of the second holes When two or more first holes are correspondingly provided, the two or more first holes are evenly distributed within the range where the second holes are located.

Further, one second hole is correspondingly provided with 2 to 5 first holes.

Specifically, the number and diameter of the first holes are set so that in the expanded state, the liquid medicine can be ejected from the first holes, and in the unexpanded state and in the unexpanded state to all During the movement in the expanded state, the medical solution remains inside the balloon or only a small amount of the medical solution seeps out from the first hole.

According to some specific and preferred embodiments, in the expanded state, the cross-sectional area of the second hole is 10-50 mm ² .

According to some specific and preferred embodiments, in the expanded state, the shape of the second hole is prismatic.

According to some specific and preferred embodiments, in the expanded state, the diameter of the first hole is 10-80 μm.

According to some specific and preferred embodiments, the distal end of the covering member is fixedly connected to the distal end of the balloon, and the proximal end of the covering member is fixedly connected to the proximal end of the balloon.

According to some specific and preferred embodiments, the covering member is configured such that when the balloon is inflated, part or all of the covering member moves relative to the outer surface of the balloon to produce a cutting effect.

Further, when the balloon is transformed from an unexpanded state to an expanded state, the contact area between part or all of the covering member and the outer peripheral surface of the balloon changes so as to realize the prevention of intravascular lesions by the covering member. Cutting of parts.

According to a more specific and preferred embodiment, the covering member comprises a plurality of covering elements and a plurality of connection points;

When the covering part is in the unexpanded state, the length of each covering element extends along the axial direction of the covering part, and a plurality of the covering elements are distributed along the circumferential direction;

Two adjacent covering elements are fixedly connected through a plurality of connecting points, and the adjacent two connecting points on the same covering element are respectively located on opposite sides of the covering element and staggered settings;

When the covering element is transformed from the unexpanded state to the expanded state, the covering element is overturned, and the two adjacent connection points connected to the same covering element respectively move toward the the balloon and in a direction away from the balloon.

Furthermore, the plurality of connection points are respectively located in a plurality of mutually parallel planes, the planes are perpendicular to the axis of the covering part, and the distances between two adjacent planes are equal.

Furthermore, when the covering element is in an unexpanded state, the width of the covering element is greater than the thickness of the covering element.

Still further, when the covering member is in an unexpanded state, the width of the covering element is 2 to 10 times the thickness of the covering element.

Furthermore, the length of the connecting point is 0.5-3 mm.

Furthermore, the thickness of the connecting point is 0.02-0.2mm.

Furthermore, the width of the connection point is 0.1-0.5 mm.

Furthermore, the thickness of the connecting point is equal to the thickness of the cladding element.

Furthermore, a plurality of said covering elements and a plurality of said connecting points jointly form a plurality of said second holes, and in said expanded state, said covering elements surround the outside of said first holes To form multiple independent administration spaces.

According to a more specific and preferred embodiment, the cladding is cut from a cylindrical pipe.

According to a more specific and preferred embodiment, the cladding member is made of metal, including but not limited to one or more of memory alloy, stainless steel, titanium alloy, nickel alloy, and cobalt-chromium alloy.

According to a more specific and preferred embodiment, when the covering member is in the expanded state, the second hole is in the shape of a prism, and in the same prism, the opposite two holes of the prism The connection points at the vertices are located on the inner side of the covering part, and the connection points at the other two opposite vertices of the prism are located on the outer side of the covering part.

According to one embodiment, the covering part further includes a first connecting part located at the distal end of the covering part and a second connecting part located at the proximal end of the covering part, and the first connecting parts are respectively It is fixedly connected with the distal end of the balloon and the distal end of the covering element, and the second connecting piece is fixedly connected with the proximal end of the balloon and the proximal end of the covering element respectively.

According to another embodiment, the covering part further includes a first connecting part located at the distal end of the covering part, a second connecting part located at the proximal end of the covering part, respectively connected to the first The proximal end of the connecting piece is fixedly connected with the distal end of the covering element and can be stretched or shortened, and the distal end of the second connecting piece and the proximal end of the covering element are connected respectively. A second extension piece that is fixedly connected and capable of being stretched or shortened, the first connecting piece is fixedly connected with the distal end of the balloon, and the second connecting piece is fixedly connected with the proximal end of the balloon the length of the first extension in the uninflated state of the balloon is less than the length of the first extension in the inflated state of the balloon, and the length of the first extension in the uninflated state of the balloon The length of the second extension is less than the length of the second extension in the expanded state of the balloon.

Furthermore, the balloon includes a first head at the distal end, a second head at the proximal end, and a balloon body fixedly connected to the first head and the second head respectively, so The first connecting piece is fixedly connected to the first head, the second connecting piece is fixedly connected to the second head, and the covering element extends over the entire outer peripheral surface of the balloon.

Furthermore, the first connecting piece and the second connecting piece are rings respectively, or have peaks and valleys arranged periodically along the circumferential direction with the axis of the covering piece as the axis, and are closed. ring.

Furthermore, in an unexpanded state, the first extension piece and the second extension piece are respectively a plurality of wavy lines centered on the axis of the covering piece and uniformly distributed along the circumferential direction.

Furthermore, in the expanded state, the junction of the first extension member and the wrapping element and the junction of the second extension member and the wrapping element are located at the position of the balloon from the unexpanded state. The location where the diameter begins to increase when transitioning to the dilated state.

Furthermore, the connection between the first connection part and the first extension part and the connection part between the second connection part and the second extension part are located between the unexpanded state and the expanded state of the balloon. The point where the diameter starts to grow when transforming.

Further, while or after the covering part is cut, the chemical solution is ejected from the first hole.

According to some specific and preferred embodiments, in said expanded state and/or during movement from said unexpanded state to said expanded state, said balloon is in contact with said covering. That is, the covering member cannot self-expand, but can only expand under the force of balloon expansion.

Further, the device for treating vascular stenosis also includes a first catheter partially located in the balloon and sealedly connected with or integrally formed with the distal end of the balloon, sheathed on the outside of the first catheter and connected to the first catheter. The proximal end of the balloon is sealingly connected or integrally formed with a second catheter, a catheter seat connected with the proximal end of the first catheter and the proximal part of the second catheter, the first catheter A drug delivery channel is formed between the second catheter and the second catheter.

Compared with the prior art, the present invention has the following advantages:

The vascular stenosis treatment device of the present invention can achieve precise positioning, and the covering part has a restrictive effect on the liquid medicine, so that the medicine can be more uniformly and effectively acted on the desired position of the blood vessel wall, thereby improving the utilization rate of the medicine and reducing the The incidence of restenosis improves the therapeutic effect.

Description of drawings

Fig. 1 is a front view of a device for treating vascular stenosis in a specific embodiment in an unexpanded state;

Fig. 2 is a partial cross-sectional view of a device for treating vascular stenosis in a specific embodiment in an unexpanded state;

Fig. 3 is a front view of a device for treating vascular stenosis in a specific embodiment in an expanded state;

Fig. 4 is a partial cross-sectional view of a device for treating vascular stenosis in an expanded state according to a specific embodiment;

Figure 5 is an enlarged view of the distal portion of Figure 2;

Figure 6 is an enlarged view of the distal portion of Figure 4;

Fig. 7 is an enlarged view of place A of Fig. 6;

Figure 8 is a front view of an embodiment of a covering in an unexpanded state;

Figure 9 is a front view of an embodiment of a covering in an expanded state;

Fig. 10 is the B-B sectional view of Fig. 9;

Fig. 11 is a front view of the relative position of the first hole and the second hole in an expanded state in another embodiment;

Fig. 12 is a front view of the relative position of the first hole and the second hole in an expanded state in another embodiment;

Figure 13 is a front view of another embodiment of a covering in an unexpanded state;

Figure 14 is a front view of another embodiment of a covering in an expanded state;

Fig. 15 is a front view of another embodiment of a covering in an unexpanded state;

Fig. 16 is a front view of another embodiment of a covering in an expanded state.

Detailed ways

In order to make the above-mentioned purpose, features and advantages of the present application more obvious and understandable, the specific implementation manners of the present application will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the application. However, the present application can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below. The technical features involved in the various embodiments of the present application may be combined with each other as long as they do not constitute a conflict with each other.

In the description of this application, it should be understood that the distal end and the proximal end are defined from the perspective of the operator, the distal end refers to the end away from the operator, and the proximal end refers to the end close to the operator. one end of the staff.

The terms "center", "longitudinal", "transverse", "length", "width", "thickness", "top", "bottom", "front", "rear", "left", "right", " Vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. The orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation or be configured in a specific orientation. and operation, and therefore should not be construed as limiting the application.

In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include at least one of these features. In the description of the present application, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

In this application, terms such as "installation", "connection", "connection" and "fixation" should be interpreted in a broad sense, for example, it may be a fixed connection or a detachable connection, unless otherwise clearly specified and limited. , or integrated; it may be directly connected, or indirectly connected through an intermediary, and may be an internal communication between two elements or an interaction relationship between two elements, unless otherwise clearly defined. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application according to specific situations.

In the present application, unless otherwise clearly specified and limited, a first feature being "on" or "under" a second feature may mean that the first and second features are in direct contact, or that the first and second features are indirect through an intermediary. touch. Moreover, "above", "above" and "above" the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. "Below", "beneath" and "beneath" the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is less horizontally than the second feature. It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements may also be present. As used herein, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions are for the purpose of illustration only and are not intended to represent the only embodiments.

1 to 6 show an exemplary blood vessel stenosis treatment device, which includes a treatment assembly 1 , a first catheter 2 , a second catheter 3 and a catheter hub 4 .

The treatment assembly 1 includes a balloon 11 and a covering member 12, and the covering member 12 covers the outside of the balloon 11 (see FIG. 5 and FIG. 6 ). The balloon 11 has an unexpanded state and an expanded state, wherein the outer diameter of the balloon 11 in the unexpanded state is smaller than the outer diameter of the balloon 11 in the expanded state; the covering member 12 expands as the balloon 11 expands. The expansion of the balloon 11 drives the covering member 12 to expand together. Since the overall rigidity of the covering member 12 is greater than that of the balloon 11, the expansion effect of the treatment assembly 1 on the stenosis of the blood vessel can be improved, and the expansion force of the balloon 11 is prevented from being blocked due to insufficient expansion force. Squeezing and deforming the stenosis can inhibit the incidence of vascular restenosis, and is especially suitable for treating atherosclerotic stenosis and stenosis with severe calcification.

The distal end of the balloon 11 is fixedly connected with or integrally formed with the distal end of the first catheter 2 so that the distal end of the balloon 11 and the distal end of the first catheter 2 are sealed. The proximal end of the balloon 11 is fixedly connected to or integrally formed with the distal end of the second catheter 3 so that the proximal end of the balloon 11 and the distal end of the second catheter 3 are sealed. The second catheter 3 is sheathed on the outside of the first catheter 2, and a drug infusion channel 13 is formed between the first catheter 2 and the second catheter 3, and the drug infusion channel 13 communicates with the balloon 11 so that the drug infusion channel 13 can pass through Medicine is injected into the balloon 11 to expand the balloon 11 .

As shown in FIGS. 5 and 6 , in some embodiments, the balloon 11 includes a first head 111 located at a distal end, a second head 112 located at a proximal end, and the first head 111 and the second head 112 respectively. Part 112 is fixedly connected to capsule body 113 . The inside of the first head 111 and the inside of the second head 112 are respectively formed with channels extending in the axial direction, and the inner diameter of the channel formed in the second head 112 is larger than the inner diameter of the channel formed in the first head 111 . The distal end of the first catheter 2 is fixedly connected or integrally formed with the proximal end of the first head 111. A lumen extending along the axial direction is formed inside the first catheter 2. The inner diameter of the lumen of the first catheter 2 is the same as that of the first catheter 2. The inner diameters of the channels formed in the first head 111 are equal, and the inner wall of the first catheter 2 is flush with the inner wall of the first head 111, so that the guide wire can pass through the lumen of the first catheter 2 and the first head 111. channel through. The distal end of the second catheter 3 is fixedly connected or integrally formed with the proximal end of the second head 112. A lumen extending along the axial direction is formed inside the second catheter 3. The inner diameter of the lumen of the second catheter 3 is the same as that of the second catheter 3. The inner diameters of the channels formed in the two heads 112 are equal, and the inner wall of the second conduit 3 is flush with the inner wall of the second head 112 , so as to facilitate the flow of medicinal liquid in the drug infusion channel 13 .

The distal end of the covering part 12 is fixedly connected to the first head 111, the proximal end of the covering part 12 is fixedly connected to the second head 112, and the covering part 12 extends on the entire outer peripheral surface of the balloon 11 (see Fig. 5 and Fig. 6), so that in the process of expanding the covering member 12 along with the balloon 11, the covering member 12 is not easy to separate from the balloon 11, causing the covering member 12 to fall off and free to other positions in the blood vessel, thereby Reduces the risk of damage to blood vessel walls.

In some embodiments, the covering member 12 cannot self-expand, but can only expand along with the expanding force of the balloon 11. More preferably, the covering member 12 is set to expand synchronously with the balloon 11, that is to say, in the expanded state And/or in the process of moving from the unexpanded state to the expanded state, the balloon 11 and the covering member 12 are always attached; of course, the definition of the balloon 11 and the covering member 12 attached here does not limit the balloon 11 and the covering member 12. The entire area of the covering member 12 is in contact, and as long as the part where the balloon 11 exerts force on the covering member 12 is in contact, the balloon 11 and the covering member 12 can be considered to be attached. By expanding the covering member 12 along with the balloon 11, the relative position of the covering member 12 and the balloon 11 can be guaranteed to be substantially unchanged, thereby facilitating the first hole 114 of the balloon 11 to be aligned with the second hole 124 of the covering member 12. corresponding (to be described in detail below).

In some embodiments, the cover 12 is configured such that when the balloon 11 is inflated, part or all of the cover 12 moves relative to the outer surface of the balloon 11 to produce a cutting effect, so that the balloon 11 is When expanding, the covering member 12 is expanded to cut the lesion in the blood vessel. In some cases, when the balloon 11 is in the expanded state and the non-expanded state, the contact area between part or all of the covering member 12 and the outer peripheral surface of the balloon 11 changes to realize the cutting of the lesion in the blood vessel by the covering member 12 ; That is, during the expansion process of the covering member 12, part or all of the covering member 12 can be turned over at a certain angle, and can be changed from being close to the outer surface of the balloon 11 to being vertical, thereby forming a cut on the lesion in the blood vessel.

In some embodiments, as shown in Fig. 8 and Fig. 9, the covering member 12 of the first embodiment, the covering member 12 includes a plurality of covering elements 121, a plurality of connection points 123, a first connecting member 127 and a second Connector 128 . The cladding member 12 in this embodiment is formed by cutting a cylindrical pipe material, for example, a part of the pipe material can be cut by laser to form a plurality of second holes 124, and the remaining part of the pipe material constitutes a plurality of cladding elements 121, a plurality of The connecting point 123 , the first connecting piece 127 and the second connecting piece 128 , in this embodiment, the first connecting piece 127 and the second connecting piece 128 are circular. Certainly, when cutting the cylindrical pipe, part of the pipe at both ends can be cut off by laser, so that the first connecting piece 127 and the second connecting piece 128 have The peaks and valleys arranged periodically in the direction are in a closed ring structure. Compared with the circular structure, the first connecting part 127 and the second connecting part 128 can be better fixed with the balloon 11, thereby improving the balloon. The firmness of the connection between the bladder 11 and the covering member 12.

In some other embodiments, as shown in Figs. 13 to 16 for the covering part 12 of the second and third embodiments, the covering part 12 further includes a first connecting part 127 located at the distal end of the covering part 12, located at The second connecting part 128 at the proximal end of the covering part 12, the first extending part 129 which is fixedly connected with the proximal end of the first connecting part 127 and the distal end of the covering element 121 respectively and can be stretched or shortened, and respectively The second extension piece 130 is fixedly connected with the distal end of the second connecting piece 128 and the proximal end of the covering element 121 and can be stretched or shortened. The first connecting part 127 is fixedly connected with the distal end of the balloon 11, and the second connecting part 128 is fixedly connected with the proximal end of the balloon 11; The length of the first extension 129 when the balloon 11 is in the expanded state, and the length of the second extension 130 when the balloon 11 is in the unexpanded state is smaller than the length of the second extension 130 when the balloon 11 is in the expanded state. In this embodiment, since the first extension piece 129 and the second extension piece 130 that can be stretched along with the expansion of the balloon 11 are added, it can better compensate for the shortening of the covering element 121 due to expansion, which is more conducive to For use with large size balloons. The first connection part 127 and the second connection part 128 of this embodiment are the same as those of the previous embodiment, and will not be repeated here. As long as the first extension piece 129 and the second extension piece 130 can be elongated or shortened, the first extension piece 129 and the second extension piece 130 shown in FIGS. In the unexpanded state, a plurality of wavy lines take the axis line of the covering part 12 as the axis and are evenly distributed along the circumferential direction. Specifically, one end of one wavy wire is fixedly connected to the ends of two adjacent cladding elements 121 , and each wavy wire is fixedly connected to the connecting piece at the corresponding end.

Among them, Fig. 13 and Fig. 14 are schematic diagrams of the second embodiment. In this embodiment, the positions where the diameters of both ends of the balloon 11 remain constant are longer, so that the first connecting part 127, the first extending part 129, the second extending part Both the member 130 and the second connecting member 128 are located at the position where the diameter of the balloon 11 remains constant. When the unexpanded state is converted to the expanded state, the balloon 11 expands so that the covering member 12 expands, and the first extension member 129 and the second extension member 129 The extension piece 130 is stretched until in the expanded state, the joints of the first extension piece 129 and the wrapping element 121 and the joints of the second extension piece 130 and the wrapping element 121 are located in the position of the balloon 11 from the unexpanded state to the expanded state. The point where the diameter starts to grow when transforming.

Among them, Fig. 15 and Fig. 16 are schematic diagrams of the third embodiment. In this embodiment, the positions where the diameters of both ends of the balloon 11 are constant are similar to the first method, so that the first connecting part 127 and the second connecting part 128 is located at the position where the diameter of the balloon 11 is constant, and the connection between the first connecting member 127 and the first extending member 129 and the connecting place between the second connecting member 128 and the second extending member 130 are located at the position where the balloon 11 moves from the unexpanded state to The position where the diameter begins to increase when the expanded state is converted. When the unexpanded state is converted to the expanded state, the balloon 11 is inflated to expand the covering member 12. While the first extension member 129 and the second extension member 130 are stretched, they approach the The end diameter of the cladding element 121 becomes larger.

The material of the covering part 12 includes but not limited to metal, and the metal includes but not limited to one or more of memory alloy, stainless steel, titanium alloy, nickel alloy, and cobalt-chromium alloy.

Wherein, as shown in FIG. 5 and FIG. 6 , the first connecting member 127 is fixedly connected with the first head 111 of the balloon 11 and the distal end of the covering element 121 respectively, and the second connecting member 128 is respectively connected with the distal end of the balloon 11. The second head 112 is fixedly connected to the proximal end of the covering element 121 , and the covering element 121 extends on the entire outer peripheral surface of the balloon 11 .

In this embodiment, as shown in FIG. 8, when the covering member 12 is in an unexpanded state, the length of each covering member 121 extends along the axial direction of the covering member 12, and the plurality of covering members 121 Evenly distributed along the circumferential direction of the covering part 12 . According to some embodiments, the number of covering elements 121 is 10-14. As shown in FIG. 10 , the number of covering elements 121 is 12. When the covering member 12 is in an unexpanded state, the width of the covering member 121 is greater than the thickness of the covering member 121. With the expansion of the balloon 11, part or all of the covering member 121 is turned over, thereby contacting the stenosis in the blood vessel. The covering element 121 is in the shape of an elongated sheet, and the surface of the covering element 121 in contact with the stenosis in the blood vessel is thinner, which has a better cutting effect, and, in the expanded state, a gap is formed between the balloon 11 and the blood vessel wall. There is a space for drug administration at a certain distance, which is beneficial for the drug solution to act on the blood vessel wall (see FIG. 9 ). Preferably, the width of the covering element 121 is 2-10 times the thickness of the covering element 121 , and more preferably, the thickness of the covering element 121 is 0.02-0.2 mm.

As shown in Figure 8, two adjacent covering elements 121 are fixedly connected by a plurality of connecting points 123, and the adjacent two connecting points 123 on the same covering element 121 are respectively located on opposite sides of the covering element 121. side and staggered from each other. Preferably, the plurality of connection points 123 are respectively located in a plurality of mutually parallel planes, the planes are perpendicular to the axis line of the covering member 12, and the distance between two adjacent planes is equal, so that the shape of the second hole 124 Much the same. Preferably, the length of the connection point 123 is 0.5-3 mm; the thickness of the connection point 123 is 0.02-0.2 mm; the width of the connection point 123 is 0.1-0.5 mm. Further preferably, the thickness of the connection point 123 is equal to the thickness of the cladding element 121 .

In this application, the thickness of the element refers to the distance between the two surfaces of the element on the radial direction of the treatment device, the width of the element refers to the distance between the two sides of the element on the circumference of the treatment device, and the length of the element refers to the distance between the two sides of the element on the treatment device. The distance between the two end surfaces of the element in the axial direction, and the thickness, width and length are all values measured when the treatment device is in an unexpanded state.

As shown in Figure 8, Figure 9, Figures 13 to 16, a plurality of cladding elements 121 and a plurality of connecting points 123 jointly form a plurality of second holes 124, and in the expanded state, the cross-sectional area of the second holes 124 is 10 ~50mm ² . When the covering member 12 is transformed from the unexpanded state to the expanded state, the covering element 121 is overturned, that is, the surface of the covering element 121 that was originally attached to the balloon 11 will move away from the balloon 11, so that the covering element 121 The lesion of the blood vessel can be cut while being expanded, and because the covering element 121 has a narrow thickness, it can have a better cutting effect on the lesion of the blood vessel. When the cladding element 121 is overturned, two adjacent connection points 123 connected to the same cladding element 121 move toward the direction of approaching the balloon 11 and away from the balloon 11 respectively. When the covering part 12 was in the expanded state, the second hole was roughly in the shape of a prism. In the same prismatic shape, the connecting points 123 at the opposite two vertices of the prismatic shape were located inside the covering part 12, and the other two prism-shaped holes were located inside the covering part 12. The connection points 123 at two opposite vertices are located on the outer side of the covering member 12, and the covering element 121 surrounds the outside of the first hole 114 to form a plurality of independent administration spaces.

The design of the structure of the covering part 12 can ensure that the covering part 12 expands together with the balloon 11, and has a good supporting force, and can provide positioning for the balloon 11, so that the medicinal liquid can be accurately applied to the desired part, and the treatment can be improved. the accuracy.

In order to avoid the drug loss of the drug on the drug-loaded balloon 11 during the delivery process, the present application opens a plurality of first holes 114 on the wall of the balloon 11, and delivers the therapeutic drug liquid into the balloon 11 to realize the balloon The expansion and ejection of the capsule 11 can reduce the loss of the drug during delivery, increase the concentration of the drug and make the dosage more precise and controllable.

By controlling the number and diameter of the first holes 114 , it is possible to control the resistance of the medicine liquid seeping out from the inside of the balloon 11 , so as to ensure that the medicine can only be ejected from the balloon 11 under a set pressure. Since the balloon 11 extends into the blood vessel, the blood in the blood vessel has a certain pressure on the balloon 11. Therefore, during the expansion of the balloon 11, the pressure outside the balloon 11 can make the liquid medicine in the balloon 11 unable to Flow out from the first hole 114 or only a small amount seeps out from the first hole 114, thereby reducing the loss of the medicinal liquid, realizing that in the expanded state, the medicinal liquid can be ejected from the first hole 114, in the unexpanded state and in the During the movement from the unexpanded state to the expanded state, the medical fluid remains inside the balloon 11 or only a small amount of medical fluid seeps out from the first hole 114 . Preferably, in the expanded state, the diameter of the first hole 114 is 20-70 μm. Wherein, ejection means that the liquid medicine can be ejected in a linear shape, and seepage means that the liquid medicine overflows only on the surface of the balloon 11 in the form of water droplets.

Wherein, by controlling the size, quantity and distribution of the first holes 114 , it is possible to control the spraying of the liquid medicine from the first holes 114 at the same time as or after cutting the covering member 12 . The distribution of the first holes 114 can be distributed on the entire outer peripheral surface of the balloon 11 as shown in FIG. 3 , or can be opened only in the upper half of the balloon 11 as shown in FIG. 11 . Wherein the distribution positions of the first holes 114 can be adjusted according to the position of the lesion in the blood vessel that needs to be administered.

In the expanded state, the diameter of the first hole 114 is smaller than the diameter of the second hole 124, the cladding element 121 is surrounded by the outside of the first hole 114, the positions of the plurality of first holes 114 and the positions of the plurality of second holes 124 Correspondingly, a plurality of relatively independent administration spaces are formed between the balloon 11 and the covering member 12 . Wherein, one second hole 124 is correspondingly provided with one or more first holes 114 . For example, FIG. 3 and FIG. 11 show that one second hole 124 corresponds to one first hole 114 . In this way, it is preferable that the axis of the first hole 114 coincides with the axis of the second hole 124 . As another example, FIG. 12 shows that one second hole 124 is correspondingly provided with two or more first holes 114 , preferably, one second hole 124 is correspondingly provided with 2 to 5 first holes 114 . In order to ensure the speed of drug administration and the uniformity of the drug solution, preferably two or more first holes 114 are evenly distributed within the range where the second holes 124 are located.

In some embodiments, in the unexpanded state, the position of the first hole 114 corresponds to the position of the second hole 124, which is beneficial to ensure that the position of the first hole 114 is consistent with the position of the second hole 124 after expansion. Correspondingly, it is not easy for the first hole 114 to be covered by the covering element 121 .

In the unexpanded state, the coverage rate of the covering member 12 on the outer peripheral surface of the balloon 11 is greater than that of the covering member 12 on the outer peripheral surface of the balloon 11 in the expanded state. In the unexpanded state, the second hole 124 is elongated. Slit-like. When the balloon 11 is transformed from the unexpanded state to the expanded state, both the first hole 114 on the balloon 11 and the second hole 124 on the cover 12 are deformed, and when the balloon 11 is in the expanded state, the second hole The degree of deformation of the first hole 124 is greater than that of the first hole 114, and both the first hole 114 and the second hole 124 become larger when the unexpanded state is converted to the expanded state.

Referring to Fig. 1 to Fig. 4, the proximal end of the first catheter 2 and the proximal end of the second catheter 3 are respectively connected to the catheter adapter 4, and the connection methods between them can be combined arbitrarily, as long as the expansion of the balloon 11 can be realized And inject the medicine solution into the blood vessel. For example, their connection mode can be that the first conduit 2 is slidably connected with the catheter adapter 4, the second conduit 3 is fixedly connected with the catheter adapter 4, or the first conduit 2 is fixedly connected with the catheter adapter 4, and the second conduit 3 is slidably connected with the catheter adapter 4, and both the first catheter 2 and the second catheter 3 are slidably connected with the catheter adapter 4, so that the axial displacement of the balloon 11 can be It is realized by the relative sliding of the catheter and the catheter adapter 4 . Certainly, their connection mode can also be that the proximal end of the first catheter 2 and the proximal end of the second catheter 3 are respectively fixedly connected with the catheter adapter 4 .

The use method of the treatment device of the present application is carried out according to the usual use method of interventional catheters. The device is placed in place, and the balloon 11 is pressurized from the catheter base 4 to expand the balloon 11, and the covering member 12 is applied on the balloon 11. Under the action force, it expands together with the balloon 11. During the expansion process, the covering part 12 cuts the stenotic part of the blood vessel, and then continues to pressurize to a certain pressure. When the pressure is higher than the set value, the liquid medicine continues to spray out. At the same time, the drug is limited in the limited administration space surrounded by the wall of the blood vessel, the covering element 121 and the wall of the balloon 11, so as to achieve the purpose of uniform administration of the blood vessel wall.

The present invention has been described in detail above, and its purpose is to allow those familiar with this field to understand the content of the present invention and implement it, and can not limit the protection scope of the present invention with this. Effect changes or modifications should be covered within the protection scope of the present invention.

Claims

A device for the treatment of vascular stenosis, comprising a treatment assembly (1), characterized in that:

The treatment assembly (1) comprises:

A balloon (11), the wall of the balloon (11) has a plurality of first holes (114) through which liquid passes, and the balloon (11) has an unexpanded state and an expanded state;

A covering (12), the covering (12) covers the outside of the balloon (11) and expands with the expansion of the balloon (11), the covering (12) has multiple A second hole (124), when the balloon (11) is in the expanded state, the diameter of the first hole (114) is smaller than the diameter of the second hole (124).
The device for treating vascular stenosis according to claim 1, characterized in that: when the balloon (11) is transformed from an unexpanded state to an expanded state, the first hole (114) and the first hole (114) on the balloon (11) The second holes (124) on the covering member (12) all become larger, and when the balloon (11) is in the expanded state, the degree of enlargement of the second holes (124) is larger than the First hole (114).
The device for treating vascular stenosis according to claim 1 or 2, characterized in that: in the unexpanded state, the coverage of the outer peripheral surface of the balloon (11) by the covering member (12) is greater than that of the expanded The coverage of the outer peripheral surface of the balloon (11) by the covering (12) in the state; and/or,

The balloon (11) is in contact with the cover (12) in the expanded state and/or during movement from the unexpanded state to the expanded state.
The device for treating vascular stenosis according to claim 1, characterized in that: in the expanded state, the positions of the plurality of first holes (114) correspond to the positions of the plurality of second holes (124) , so that a plurality of relatively independent administration spaces are formed between the balloon (11) and the covering member (12); and/or, in the unexpanded state, the first hole (114 ) corresponds to the position of the second hole (124); and/or, one second hole (124) is correspondingly provided with one or more than one first hole (114).
The device for treating vascular stenosis according to claim 4, characterized in that: when one of the second holes (124) is correspondingly provided with one of the first holes (114), the axis of the first hole (114) The center line coincides with the axis line of the second hole (124); when one second hole (124) is correspondingly provided with two or more than two first holes (114), two or More than two first holes (114) are uniformly distributed within the range of the second holes (124); and/or,

One second hole (124) is correspondingly provided with 2 to 5 first holes (114).
The device for treating vascular stenosis according to claim 1, characterized in that: the number and diameter of the first holes (114) are set so that in the expanded state, the medicinal liquid can pass through the first holes (114) In the unexpanded state and during the movement from the unexpanded state to the expanded state, the medicinal liquid remains inside the balloon (11) or only a small amount of medicinal liquid exits the first hole (114) Exudation; and/or,

In the expanded state, the cross-sectional area of the second hole (124) is 10-50 mm 2 , and/or, the shape of the second hole (124) is prismatic, and/or, the first The diameter of one hole (114) is 10 μm-80 μm.
The device for treating vascular stenosis according to claim 1, characterized in that: the distal end of the covering member (12) is fixedly connected with the distal end of the balloon (11), and the covering member (12) The proximal end is fixedly connected with the proximal end of the balloon (11); and/or,

The device for the treatment of vascular stenosis also includes a first catheter (2) partly located in the balloon (11) and the distal end of which is sealingly connected or integrally formed with the distal end of the balloon (11), sleeved on the The outside of the first catheter (2) and the second catheter (3), which is sealed and connected with the proximal end of the balloon (11) or integrally formed, is respectively connected with the proximal end of the first catheter (2) and The proximal end of the second catheter (3) is connected to a catheter seat (4), and a drug delivery channel (13) is formed between the first catheter (2) and the second catheter (3).
The device for treating vascular stenosis according to claim 1 or 7, characterized in that: the covering member (12) is configured as a part of the covering member (12) when the balloon (11) expands Or all of them generate relative movement relative to the outer surface of the balloon (11) to generate cutting action.
The device for treating vascular stenosis according to claim 8, characterized in that: when the balloon (11) is transformed from an unexpanded state to an expanded state, part or all of the covering member (12) is in contact with the balloon The contact area of the outer peripheral surface of the capsule (11) is changed to realize the cutting of the lesion in the blood vessel by the covering member (12); and/or,

At the same time as or after the cutting of the covering member (12), the chemical liquid is ejected from the first hole (114).
The device for treating vascular stenosis according to claim 9, characterized in that: the covering member (12) comprises a plurality of covering elements (121) and a plurality of connection points (123);

When the covering member (12) is in the unexpanded state, the length of each covering element (121) extends along the axis of the covering member (12), and a plurality of the covering members (121) The cladding elements (121) are distributed along the circumferential direction;

Two adjacent covering elements (121) are fixedly connected through a plurality of connecting points (123), and two adjacent connecting points (123) on the same covering element (121) ) are respectively located on opposite sides of the cladding element (121) and are staggered from each other;

When the covering member (12) is transformed from the unexpanded state to the expanded state, the covering element (121) is reversed and connected to the corresponding covering element (121) The two adjacent connecting points (123) move towards the direction of approaching the balloon (11) and away from the balloon (11) respectively.
The device for treating vascular stenosis according to claim 10, characterized in that: a plurality of connection points (123) are respectively located in a plurality of mutually parallel planes, and the planes are aligned with the axis of the covering member (12). lines are perpendicular, and two adjacent said planes are equidistant; and/or,

In the unexpanded state of the covering (12), the width of the covering element (121) is greater than the thickness of the covering element (121); and/or,

The length of the connection point (123) is 0.5-3 mm; and/or, the thickness of the connection point (123) is 0.02-0.2 mm; and/or, the width of the connection point (123) is 0.1-0.5 mm mm; and/or, the thickness of the connection point (123) is equal to the thickness of the cladding element (121); and/or,

A plurality of said covering elements (121) and a plurality of said connecting points (123) jointly form a plurality of said second holes (124), and in said expanded state, said covering elements (121) surround outside the first hole (114) to form a plurality of independent administration spaces; and/or,

When the covering member (12) is in the expanded state, the second hole (124) is in the shape of a prism, and in the same prism, the connecting points at the two opposite vertices of the prism (123) is located on the inner side of the covering part (12), and the connection points (123) at the other two opposite vertices of the prism are located on the outer side of the covering part (12).
The device for treating vascular stenosis according to claim 11, characterized in that: when the covering member (12) is in an unexpanded state, the width of the covering element (121) is 2 to 10 times the thickness.
The device for treating vascular stenosis according to claim 8, characterized in that: the covering member (12) is cut from a cylindrical pipe; and/or, the material of the covering member (12) is metal and/or, the cladding member (12) is made of one or more of memory alloy, stainless steel, titanium alloy, nickel alloy, and cobalt-chromium alloy.
The device for treating vascular stenosis according to claim 10, characterized in that: the covering part (12) further comprises a first connecting part (127) located at the distal end of the covering part (12) and a connecting part (127) located at the distal end of the covering part (12). The second connecting piece (128) at the proximal end of the covering member (12), the first connecting piece (127) is respectively connected to the distal end of the balloon (11) and the distal end of the covering element (121). The end is fixedly connected, and the second connecting member (128) is fixedly connected with the proximal end of the balloon (11) and the proximal end of the covering element (121) respectively; and/or,

The covering part (12) also includes a first connecting part (127) located at the distal end of the covering part (12), a second connecting part (128) located at the proximal end of the covering part (12) ), respectively fixedly connected with the proximal end of the first connecting member (127) and the distal end of the covering element (121) and capable of elongation or shortening of the first extension member (129), and respectively with the The distal end of the second connecting part (128) is fixedly connected with the proximal end of the covering element (121) and can be extended or shortened second extension part (130), the first connecting part (127) It is fixedly connected with the distal end of the balloon (11), and the second connecting member (128) is fixedly connected with the proximal end of the balloon (11); when the balloon (11) is not inflated The length of the first extension (129) in the state is smaller than the length of the first extension (129) in the expanded state of the balloon (11), and the length of the first extension (129) in the unexpanded state of the balloon (11) The length of the second extension part (130) is smaller than the length of the second extension part (130) when the balloon (11) is in an expanded state.
The device for treating vascular stenosis according to claim 14, characterized in that: the balloon (11) comprises a first head (111) at the far end, a second head (112) at the proximal end, and a second head (112) at the proximal end, respectively The first head (111) and the second head (112) are fixedly connected to the capsule (113), and the first connecting member (127) is fixed to the first head (111) connected, the second connecting member (128) is fixedly connected with the second head (112), and the covering element (121) extends on the outer peripheral surface of the entire balloon (11); and/or,

The first connecting part (127) and the second connecting part (128) are rings respectively, or have peaks that take the axis of the covering part (12) as the axis and are periodically arranged along the circumferential direction. , a valley, and a closed loop; and/or,

In the unexpanded state, the first extension piece (129) and the second extension piece (130) are respectively centered on the axis line of the covering piece (12) and uniformly distributed along the circumferential direction. multiple tildes; and/or,

In the expanded state, the connection between the first extension (129) and the covering element (121) and the connection between the second extension (130) and the covering element (121) are located at the The position where the diameter of the balloon (11) begins to increase when it transitions from an unexpanded state to an expanded state; and/or,

The connection between the first connection part (127) and the first extension part (129) and the connection part between the second connection part (128) and the second extension part (130) are located in the balloon (11) The position where the diameter begins to increase when transitioning from the unexpanded state to the expanded state.